eligibility_summary
Inclusion: advanced solid tumors (e.g., LSCC, ESCC, HNSCC, MSS-CRC refractory after >=2 SOC incl. anti-PD-L1), adequate hematologic/renal/hepatic labs, ECOG 0-1, contraception, compliance. Exclusion: recent anticancer therapy/investigational, anti-CD38 <90d, active other cancers, significant ocular disease or grade 3 paresis, prior DLT irAE on PD-1, INR/aPTT >1.5x ULN, neuropathy >=G3 or G2 w/pain, NYHA >2, QTcF >470 ms, strong CYP3A4/2B6/1A2 or P-gp/BCRP inhibitors/inducers, symptomatic/untreated brain mets or CNS disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05584709 tests STI-6129, an anti-CD38 antibody–drug conjugate (biologic) given IV every 4 weeks in advanced solid tumors. Mechanism: the monoclonal antibody binds CD38, is internalized, and releases a cytotoxic payload to kill tumor cells, Fc-mediated effector functions (ADCC/CDC) may contribute. Targets: CD38-expressing malignant cells and the CD38 ectoenzyme pathway within the tumor microenvironment (linked to adenosine-mediated immunosuppression). The trial uses 3+3 dose escalation to define MTD/RP2D.